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FDA warns veterinarians and producers about violative residues

By Kate O'Rourke

Posted Sept. 15, 2003

This past summer, between early May and the end of July, the Food and Drug Administration issued warning letters to 14 individuals for violating the Federal Food, Drug, and Cosmetic Act and causing illegal drug residues to end up in animals intended for food. The individuals, two of whom were veterinarians, were asked to establish procedures to avoid repeating the mistake, or risk further regulatory action.

While the percentage of violative residues is low, incidents do occur (see JAVMA, June 15, 2003, page 1658). Some illegal residues exist because individuals use incorrect withdrawal times. And in other situations, certain antimicrobials are being used incorrectly within a species. Fluoroquinolones, for example, are prohibited for use in cattle intended for dairy production; they cannot even be stored in the milk house, milking barn, stable, or parlor.

According to Gloria Dunnavan, director of the Division of Compliance at the FDA Center for Veterinary Medicine, dairy cows that are culled because of a health issue are one of the classes of animals that are often found to have illegal residues. This is what happened to a California-based veterinarian who received a warning letter in July; he instructed that a dairy cow be treated with penicillin, after which the animal was slaughtered.

The warning letter reminded the veterinarian that, prior to prescribing or dispensing an approved new animal drug for an extralabel use in food animals, the veterinarian must establish a substantially extended withdrawal period prior to marketing an edible product; institute procedures to ensure maintenance of the treated animal's identity; and take appropriate measures to ensure that assigned time frames for withdrawal are met. This includes specifying a withdrawal/discard time on a drug label for any food that might be derived from a treated animal.

In another case, a South Dakota-based veterinarian violated the Federal Food, Drug, and Cosmetic Act by, among other things, compounding and distributing animal drugs for extralabel use without a valid veterinarian-client-patient relationship. He also violated the law by compounding without determining that there were not approved animal or human drugs that would be effective in treating a condition; compounding from human drugs when an approved animal drug could have been used; and compounding and distributing drug products without proper labeling information. The veterinarian was issued a warning letter for these violations as well as for selling medicated feed premixes that were considered adulterated because of inadequate labeling.

According to Dunnavan, veterinarians have a responsibility to follow the regulations and educate their clients to make sure they are compliant. In many cases, the client may actually be administering the drug.

Individuals can obtain a copy of the "FDA and the Veterinarian" booklet as well as an Animal Medicinal Drug Use Clarification Act brochure, free of charge, from the AVMA by calling (800) 248-2862, Ext. 6636.